Latino Teen Pregnancy Prevention K23

Pregnancy in Adolescence Clinical Trial

Official title:

Reducing Reproductive Health Disparities Among Latino Youth Living in Rural Communities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105905
• Other study ID #: STUDY00002128
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: September 2027

Study information

• Verified date: October 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: Romina L Barral
• Phone: 816-960-4152
• Email: rlbarral[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.

Description:

The study uses questionnaires and interviews with youth and community members, to co-develop and pilot test an unintended teen pregnancy prevention intervention in an emerging immigrant Latino rural community, aiming to decrease reproductive health disparities in marginalized communities across the country. To achieve this objective, the team will conduct interviews and co-development sessions, to ensure input from key stakeholders in the community, when developing an intervention. Delineation of Activities: Research Activities • Aim 1: Through stakeholder-engaged research, the team will identify key factors (at multiple levels of influence as defined by NIMHD) needed for the co-development of an acceptable and effective teen pregnancy prevention intervention for rural Latino teens: The team will conduct up to 60 key informant interviews to identify barriers to and facilitators of teen pregnancy prevention programming, such as cultural and social norms. Participants will complete a survey to collect demographic data before participating in the interview. Interviews will last 45 to 60 minutes, in either Spanish or English depending on participants' preference, and will be done using video conference tools at the interviewee's location and times of preference to accommodate participants' schedules. • Aim 2: Using the transcreation framework, co-develop with community partners a teen pregnancy prevention intervention that best fits the community's unique needs and context: Up to 50 key stakeholders will participate in approximately 8 co-development hybrid sessions to discuss, draft, and redraft each module of the Cuidate intervention syllabus, interactive course materials, and activities. The goal of the workgroup is to discuss recommendations and unique needs of local Latino teens (Specific Aim 1) and modify Cuidate in response to local insights. These sessions will be facilitated by the study research team in either Spanish or English depending on the participants' preference. The sessions will be done using a hybrid method that could include in-person interactions and/or video conference tools at the interviewee's location and times of preference to accommodate participants' schedules. Virtual co-development sessions will be conducted via Microsoft Teams. University of Kansas (KU) will utilize Zoom as an alternative option for virtual meetings. In that instance, KU will initiate the Zoom call. In-person, interviews may be conducted at a local church, and/or at a location managed by a Juntos Community Health Specialists. • Aim 3: Conduct a pilot study to evaluate the feasibility of a co-created teen pregnancy prevention intervention in target Latino rural communities: The co-developed intervention will be delivered in a workshop format by facilitators, over two consecutive days for 3.5 hours each day. Feedback on delivery mode (virtual, in-person, or hybrid) will be elicited during the co-development sessions. If in-person/hybrid is suggested, information will be collected about preferred location (e.g., a local community center, sports club, etc.). Five groups of 10 participants each, stratified by gender and age (14-15 years old and 16-18 years old; females and males) will complete sessions, in either Spanish or English depending on participants' preference, using video conference tools. After the delivery of the intervention, facilitators will take field notes and complete a debriefing questionnaire to assess practicality and fidelity. Teens will complete a 15-minute survey pre-intervention, immediately after the 2-day intervention, and three-month post-intervention (computer-assisted, self-administered, online via Research Electronic Data Capture - REDCap). Surveys will assess acceptability and risk behaviors. As in the published Cuidate trials, previously used measures will be used to document validity and comparability. Surveys will be de-identified; participants will create a code to match surveys without using identifying data. Those currently enrolled are only from non-trial aims in this module.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• 14-18 years old,
• self-identify as Latino,
• speak English or Spanish

Exclusion Criteria:

• non-English or non-Spanish speaking
• developmental delayed
• have significant behavioral health issues which may interfere with study participation
• incarcerated minors
• minors in foster care.

Related Conditions & MeSH terms

• Pregnancy in Adolescence
• Rural Health

Intervention

Behavioral:
• Healthy futures ("Futuros Saludables")
The developed intervention will be delivered in a workshop format by facilitators, over two consecutive days for 3.5 hours each day. Feedback on delivery mode (virtual, in-person, or hybrid) during the co-development sessions. If in-person/hybrid is suggested, feedback will be elicited about preferred location (e.g., a local community center, sports club, etc.). Five groups of 10 participants each, stratified by gender and age (14-15 years old and 16-18 years old; females and males) will complete sessions, in either Spanish or English depending on participants' preference, using video conference tools. After the delivery of the intervention, facilitators will take field notes and complete a debriefing questionnaire to assess practicality and fidelity. Teens will complete a 15-minute survey pre-intervention, immediately after the 2-day intervention, and three-month post-intervention. Surveys will assess acceptability and risk behaviors.

Locations

Country	Name	City	State
United States	Childrens Mercy Hospital and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale.	This outcome measure identifies the degree in which the intervention is accepted by the participant. Acceptability refers to the extent at which the intervention is perceived as agreeable, or satisfactory to the participant. Acceptability is measured using a Likert Scale in a survey immediately after the 2-day intervention is administered. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention Meets my approval, 2) Newly Approved Intervention is appealing to me, 3) I like the Newly Approved Intervention, 4) I welcome the Newly Approved Intervention.	Immediately after 2-day intervention
Primary	A survey to determine the participants perception of intervention applicability of conducted intervention using a Likert Scale.	This outcome measure identifies the extent in which a participant assesses the appropriateness of the conducted intervention. Appropriateness refers to the perceived ft, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and/or perceived ft of the innovation to address a particular issue or problem. Appropriateness is measured using a Likert Scale in a survey immediately after the 2-day intervention is administered. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention seems fitting, 2) Newly Approved Intervention seems suitable, 3) Newly Approved Intervention seems applicable, 4) Newly Approved Intervention seems like a good match.	Immediately after 2-day intervention.
Primary	A survey to determine the facilitators perception of the difficulty of implementing the intervention.	This outcome measure identifies the feasibility for facilitators to conduct the intervention. Feasibility refers to the extent to which an innovation "can be success- fully used or carried out within a given agency or setting". Feasibility will be measured using the facilitator survey that employs a Likert Scale. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention seems implementable, 2) Newly Approved Intervention seems doable, 3) Newly Approved seems easy to use. Feasibility will also be measured using ethnographic field notes that are analyzed using inductively using a grounded theory approach. Weekly meetings will allow for resolution of discrepancies and to establish inter-rater reliability.	Facilitator surveys will occur immediately post 2-day intervention. Field notes will be collected during the delivery of the intervention.
Secondary	A survey analysis of teen sexual behavior risk pre and post intervention.	This outcome measure analyzes teens' sexual behaviors, to determine their overall sexual risk. The outcome measure analyzes participant condom usage and multiple partners as identities of risk over the last 90 days. The survey is designed to identify if sexual risk is decreased post-intervention for participants (Increase in condom usage and decrease in the number of sexual partners).	15-minute survey pre-intervention, and three-month post-intervention
Secondary	A survey analysis of teen sexual intention pre and post intervention.	A survey analysis of teen sexual intention pre and post intervention. The survey will analyze the following "Attitudes towards protection, Attitudes towards risky behavior, Knowledge of pregnancy risk, Knowledge of sexually transmitted infections risk, Motivation to delay childbearing, Intention measures, Refusal skills, condom negotiation skills" This survey aims to examine if sexual intentions and knowledge have changed between pre and post intervention.	15-minute survey pre-intervention, and three-month post-intervention